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Enriqueta Felip
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ESMO-IASLC Best Abstracts (ID 62)
- Event: ELCC 2019
- Type: Proffered Paper session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/11/2019, 14:45 - 16:15, Room B
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103O_PR - Safety and efficacy of pembrolizumab (Pembro) monotherapy in elderly patients (Pts) with PD-L1–positive advanced NSCLC: Pooled analysis from KEYNOTE-010, -024, and -042 (ID 466)
14:45 - 16:15 | Author(s): Enriqueta Felip
- Abstract
- Presentation
Background
Approximately 70% of newly-diagnosed NSCLC cases occur in the elderly, and more than half are locally advanced/metastatic. We present a pooled analysis of efficacy and safety in elderly pts (aged ≥75 y) enrolled in 3 randomized controlled trials of pembro monotherapy vs standard chemotherapy (chemo) for PD-L1–positive advanced NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Pts were aged ≥18 y with advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥1% (KEYNOTE-010, -042) or TPS ≥50% (KEYNOTE-024). In KEYNOTE-010, pts were randomized to pembro 2 or 10 mg/kg Q3W or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and -042, pts were randomized to first-line pembro 200 mg Q3W or platinum-based chemo. OS was estimated by the Kaplan-Meier method.
20c51b5f4e9aeb5334c90ff072e6f928 Results
The 3 trials included 264 pts aged ≥75 (range, 75–90) y with TPS ≥1%; 132 pts had TPS ≥50%. Independent of line of treatment, HRs (95% CI) for OS favored pembro vs chemo: 0.76 (0.56–1.02) in pts with TPS ≥1% and 0.40 (0.25–0.64) in pts with TPS ≥50%. Pembro also improved OS vs chemo in the pooled analysis of pts with TPS ≥50% who received first-line therapy (KEYNOTE-024 and -042): HR, 0.41 (95% CI, 0.23–0.73). Overall, fewer treatment-related AEs across various categories were observed with pembro vs chemo, in particular, grade 3–5 treatment-related AEs in pts aged ≥75 y (Table). Immune-mediated AEs and infusion reactions were more frequent with pembro vs chemo, with similar frequency in pts receiving pembro aged ≥75 y and <75 y (Table).
fd69c5cf902969e6fb71d043085ddee6 Conclusions
In this pooled analysis of pts aged ≥75 y with PD-L1–positive advanced NSCLC, pembro monotherapy improved OS vs chemo, both in pts with PD-L1 TPS ≥1% and PD-L1 TPS ≥50%. The safety profile of pembro was similar in pts aged ≥75 y and <75 y, with lower rates of grade 3–5 treatment-related AEs vs chemo.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT01905657 (KEYNOTE-010); NCT02142738 (KEYNOTE-024); NCT02220894 (KEYNOTE-042).
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing and editorial assistance was provided by Michael S. McNamara, MS, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
213f68309caaa4ccc14d5f99789640ad Funding
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
682889d0a1d3b50267a69346a750433d Disclosure
K. Nosaki: Honoraria: AstraZeneca, Chugai Pharmaceutical, Eli Lilly, MSD; Institutional research funding: MSD. Y. Hosomi: Personal fees: MSD, AstraZeneca, Eli Lilly Japan, Taiho Pharmaceutical, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb. H. Saka: Grants/research support: AstraZeneca, MSD, Ono Pharmaceutical; Honoraria: AstraZeneca, MSD, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Kyorin Pharmaceutical. P. Baas: Consulting role: Genentech/Roche, Merck, Bristol-Myers Squibb, Pfizer; Research support: Bristol-Myers Squibb, Roche, Merck. G. de Castro Jr: Consulting/advisory role: AstraZeneca, MSD, BMS, Roche, Novartis, Boehringer Ingelheim; Speakers’ bureau: MSD, BMS, Novartis, AstraZeneca; Travel/accommodation expenses: MSD, BMS, Roche, Bayer, Novartis, Boehringer Ingelheim, AstraZeneca. M. Reck: Personal fees: Amgen, Hoffmann-La Roche, Lilly, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, MSD, Merck, Novartis, Pfizer, AbbVie. Y-L. Wu: Honoraria: AstraZeneca, Eli Lilly, Roche, Pierre Fabre, Pfizer, Sanofi; Consulting/advisory role: AstraZeneca, Roche, Merck, Boehringer Ingelheim; Research funding to institution: Boehringer Ingelheim, Roche. J.R. Brahmer: Grant, personal fees, Advisory boards, consulting: Merck; Uncompensated advisor and consultant: Bristol-Myers Squibb; Grants: Bristol-Myers Squibb, MedImmune/AstraZeneca; Personal fees: Amgen, Celgene, Lilly. E. Felip: Consulting, advisory role, speaker’s bureau: AbbVie, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Guardant Health, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda; Research funding: Fundación Merck Salud; Grant for Oncology Innovation EMD Serono. T. Sawada, K. Noguchi, S.R. Han: Employee: MSD K.K., Tokyo, Japan. B. Piperdi, D.A. Kush: Employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. G. Lopes: Research funding to institution: Merck & Co., Inc., EMD Serono, AstraZeneca.
cffcb1a185b2d7d5c44e9dc785b6bb25Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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Immunotherapy in stage IV (ID 13)
- Event: ELCC 2019
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/11/2019, 09:00 - 10:30, Room B
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Predictive diagnostics and treatment algorithms (ID 36)
09:00 - 10:30 | Presenting Author(s): Enriqueta Felip
- Abstract
- Presentation
Abstract not provided
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Lunch & Poster Display session (ID 58)
- Event: ELCC 2019
- Type: Poster Display session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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180TiP - An open-label, randomized, phase I/II trial of IO102 and pembrolizumab, or IO102, pembrolizumab and chemotherapy, as first-line treatment for patients with metastatic non-small cell lung cancer (ID 208)
12:30 - 13:00 | Author(s): Enriqueta Felip
- Abstract
Background
Immunotherapy has significantly changed the treatment landscape of non-small cell lung cancer (NSCLC) with no driver mutations. However, despite the addition of anti-PD-1/PD-L1 therapies to the clinical armamentarium only a subset of patients derives durable benefit. IO102 is a novel, second generation, HLA-A unrestricted immune modulating T-win® vaccine targeting IDO. IO102 has a dual mode of action; remodulation of the tumour micro-environment through elimination of immune suppressive cells and induction of CD8 T-cell mediated killing of IDO-expressing tumor cells. Our first-generation IDO vaccine (IO101) has shown promising antitumor activity and a favorable safety in heavily pretreated NSCLC patients (Iversen, CCR 2013).
a9ded1e5ce5d75814730bb4caaf49419 Trial design
Phase I/II, international, multicenter, open-label, randomized trial with two parallel cohorts. Cohort A: IO102 (100µg s.c.) and pembrolizumab (200 mg) (PD-L1 ≥ 50%); Cohort B: IO102, pembrolizumab and carboplatin plus pemetrexed (PD-L1 < 50%). The maximum treatment duration is 35 cycles (app. 2 years). Key eligibility criteria include metastatic NSCLC or non-squamous NSCLC (cohort B) with no prior treatment for metastatic NSCLC and no driver mutations. Phase I is a non-randomized safety run-in with 6 patients per cohort investigating one dose level of the experimental arms. Only one DLT is allowed in each cohort. Phase II is following Sargent’s two-stage, three-outcome optimum design (Sargent, ClinTrial2001) with a 2:1 randomization in the cohorts. Cohort A: IO102 and pembrolizumab versus pembrolizumab alone; Cohort B: IO102, pembrolizumab and chemotherapy vs. pembrolizumab and chemotherapy. Provision of blood and tumour tissue is required for biomarker studies. The primary endpoint is safety and objective response rate (ORR) per RECIST 1.1 in Phases I and II, respectively. Secondary endpoints include ORR per iRECIST, duration of response, progression free survival, overall survival, and biomarkers including immunoscore in tissue, tumour mutational burden and immunomonitoring in blood. The study is enrolling in Europe and US: EudraCT Number 2018-000139-28 / IND Number 018081.
d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification
EudraCT 2018-000139-28 / IND Number: 018081.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study
IO Biotech.
213f68309caaa4ccc14d5f99789640ad Funding
IO Biotech.
682889d0a1d3b50267a69346a750433d Disclosure
J. Spicer: Research funding, honoraria (institutional): Achilles, AstraZeneca, Bayer, BerGenBio, Boehringer Ingelheim, BMS, Celgene, Curis; Genmab, Roche, Shionogi, Starpharma, Taiho; Co-founder, shareholder: IGEM Therapeutics. P. Garrido Lopez: Consulting, advisory: I4, MSD, BMS, Boerhinger Ingelheim, Pfizer, AbbVie, Guardant Health, Novartis, Lilly, AstraZeneca, Janssen, Sysmex, Blueprint Medicines, Takeda; Speaker: Roche, MSD, BMS, Pfizer, Novartis, Boerhinger Ingelheim. J. Bosch-Barrera: Advisory board: MSD. E. Felip: Advisory: Blue Print Medicines, Celgene, Guardant Health, Janssen; Advisory, speaker: AbbVie, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda; Consultant: Boehringer Ingelheim. J. Trigo: Advisory board: Takeda, BMS, Boehringer; Speaker: BMS, Boehringer, Roche, AstraZeneca. S. Viteri: Speaker fees: BMS, Roche; Travel fees: Servier, Roche, Merck Serono; Advisory fees: Roche, AbbVie; Research fees: Roche, BMS, Servier, Merck Serono, AbbVie, Janssen. E. Schmidt: Employed: Merck & Co., Inc. A.V. Christiansen, E. Ehrnrooth: Employed: IO Biotech; Member of the Safety Monitoring Committee for the IO102-012/KN-764 trial. M-B. Zocca: Chief Executive Officer, founder: IO Biotech; Member of the Safety Monitoring Committee for the IO102-012/KN-764 trial. M.H. Andersen: Chief Scientific Officer, founder, member of BoD: IO Biotech. L. Paz-Ares: Advisory board: Roche, Lily, MSD, BMS, Boehringer Ingelheim, Novartis, AstraZeneca, Amgen, Pfizer. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25 -
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182TiP - A phase II trial of tepotinib in patients with non-small cell lung cancer (NSCLC) harboring MET alterations: The VISION study (ID 452)
12:30 - 13:00 | Author(s): Enriqueta Felip
- Abstract
Background
Dysregulation of the MET pathway is common in human carcinomas and leads to dependency on MET signalling, representing a potential therapeutic target in NSCLC. MET alterations including MET-exon 14 skipping mutations (METex14) and MET amplification (METamp) are known oncogenic drivers, and occur in 3–4% and 0.4–1.5% of NSCLCs, respectively. Tepotinib, a potent selective, small molecule MET inhibitor, has shown promise in preclinical and phase 1 trials.
a9ded1e5ce5d75814730bb4caaf49419 Trial design
VISION (NCT02864992), a single-arm, open-label, multicentre Phase 2 trial, will assess the antitumour activity and tolerability of tepotinib 500 mg daily, as 1st–3rd line of treatment, in patients with histologically-confirmed, advanced (stage IIIB/IV) NSCLC (all histologies) harboring MET alterations. Patients with METex14 + (determined by tumor biopsy [TBx] and/or plasma ‘liquid’ biopsy [LBx]; Cohort A) or METamp (determined by LBx; Cohort B) NSCLC are included. Prior treatment with checkpoint inhibitors is permitted. Patients with epidermal growth factor receptor-activating mutations, anaplastic lymphoma kinase rearrangements, or with brain metastasis as the only measurable lesion are excluded. The primary endpoint is objective response rate (ORR) by independent review committee via Response Evaluation Criteria in Solid Tumors v1.1. Secondary objectives include investigator-assessed ORR, duration of response, disease control, progression free survival, overall survival, tolerability, and safety. Adverse events (AEs) will be monitored throughout the study and for 30 days (90 days for serious AEs) after treatment and graded per National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. Enrolment into Cohort A commenced in September 2016 and is continuing. Enrolment of patients with LBx-confirmed METamp into Cohort B commenced in September 2018; based on an interim analysis of 12 patients, recruitment may continue to enrol ≥60 patients. This abstract was previously presented at ESMO Asia 2018, FPN 546TiP, Paik et al. Reused with permission.
d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification
NCT02864992.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing assistance (funded by Merck KGaA, Darmstadt, Germany) was provided by Lisa Jolly, Bioscript Science (Macclesfield, UK).
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
Merck KGaA.
213f68309caaa4ccc14d5f99789640ad Funding
Merck KGaA.
682889d0a1d3b50267a69346a750433d Disclosure
P. Paik: Advisory board, honorarium: Celgene; IDMC: Takeda. A. Cortot: Advisory boards member: AstraZeneca, BMS, MSD, Pfizer, Novartis, Roche, Takeda, Boehringer Ingelheim; Corporate-sponsored research: Merck. E. Felip: Speaker’s bureau, advisory board: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celegene, Eli Lilly, Guardant Health, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, AbbVie, Merck. J. Mazieres: Advisory board: Roche, BMS, MSD, AstraZeneca, Pfizer, Novartis. F. Griesinger: Scientific support: ASTRA, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens; Talks, presentations, advisory boards: ASTRA, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, ARIAD, AbbVie, Siemens. R. Bruns, J. Scheele, J. Straub: Employee: Merck KGaA, Darmstadt, Germany. R. Veillon: Congress registration, advisory board: Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme, Roche, Pfizer, AbbVie, Merck. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25
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Pfizer Oncology - Industry Satellite Symposium (ID 37)
- Event: ELCC 2019
- Type: Industry Satellite symposium
- Track:
- Presentations: 3
- Moderators:
- Coordinates: 4/12/2019, 13:00 - 14:00, Room C
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Introduction (ID 655)
13:00 - 14:00 | Presenting Author(s): Enriqueta Felip
- Abstract
Abstract not provided
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Q&A (ID 659)
13:00 - 14:00 | Presenting Author(s): Enriqueta Felip
- Abstract
Abstract not provided
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Where did we start? (ID 656)
13:00 - 14:00 | Presenting Author(s): Enriqueta Felip
- Abstract
Abstract not provided
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Proffered Paper session III (ID 64)
- Event: ELCC 2019
- Type: Proffered Paper session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/12/2019, 08:30 - 10:00, Room A
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106O - Brigatinib (BRG) vs crizotinib (CRZ) in the phase III ALTA-1L trial (ID 166)
08:30 - 10:00 | Author(s): Enriqueta Felip
- Abstract
- Presentation
Background
We report results of the first interim analysis (IA) from the ALTA-1L study of BRG vs CRZ in anaplastic lymphoma kinase (ALK) inhibitor–naive, ALK-positive non–small cell lung cancer (ALK+ NSCLC; NCT02737501).
a9ded1e5ce5d75814730bb4caaf49419 Methods
This open-label, multicenter study enrolled patients (pts) with advanced ALK+ NSCLC. Eligible pts had ≤1 prior systemic therapy for advanced NSCLC. Asymptomatic central nervous system (CNS) metastases were allowed. Pts were randomized 1:1 to BRG 180 mg QD with 7-day lead-in at 90 mg or CRZ 250 mg BID. Primary endpoint was blinded independent review committee (BIRC)-assessed progression-free survival (PFS; RECIST v1.1); secondary efficacy endpoints included BIRC-assessed objective response rate (ORR), intracranial ORR (iORR), and intracranial PFS (iPFS). IAs were planned at 50% and 75% of 198 expected PFS events.
20c51b5f4e9aeb5334c90ff072e6f928 Results
275 pts were randomized (BRG/CRZ, n = 137/138); median age (years) 58/60. 26%/27% received prior chemotherapy for advanced disease, and 29%/30% had baseline brain metastases. At data cutoff (19 Feb 2018), with a median follow-up of 11.0/9.3 months (BRG/CRZ) and 99 PFS events, BRG met the prespecified threshold for statistical superiority vs CRZ in the primary endpoint of BIRC-assessed PFS (HR 0.49; 95% CI, 0.33–0.74; log-rank P = 0.0007); BRG median PFS was not reached (NR; 95% CI, NR) vs CRZ 9.8 months (95% CI, 9.0–12.9). Investigator-assessed PFS HR 0.45 (95% CI, 0.30–0.68); log-rank P = 0.0001. Table shows additional efficacy data. Most common grade ≥3 treatment-emergent adverse events (AEs): BRG: increased blood creatine phosphokinase (16.2%) and lipase (13.2%), hypertension (9.6%); CRZ: increased alanine aminotransferase (9.5%), aspartate aminotransferase (5.8%), and lipase (5.1%). Any grade interstitial lung disease/pneumonitis: BRG, 3.7%; CRZ, 2.2%. Discontinuations due to AE (BRG/CRZ): 11.8%/8.8%.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
BRG showed a statistically and clinically significant improvement in PFS vs CRZ in ALK inhibitor–naive ALK+ NSCLC.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT02737501.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Professional medical writing assistance was provided by Lauren Gallagher, PhD, (Peloton Advantage, Parsippany, NJ) and funded by Millennium Pharmaceuticals, Inc.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
213f68309caaa4ccc14d5f99789640ad Funding
ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
682889d0a1d3b50267a69346a750433d Disclosure
R. Califano: Honoraria, consulting/advisory role: AstraZeneca, BMS, Roche, MSD, Boehringer Ingelheim, Takeda, Novartis, Pfizer, Lilly Oncology. C. Gridelli: Speakers bureau, advisory role: Pfizer, Roche. A. Delmonte: Consulting/advisory role: AstraZeneca, Boehringer Ingelheim. M.R. Garcia Campelo: Honoraria: ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim; Speakers bureau, advisory role: ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim. A. Bearz: Speakers bureau, advisory role: AstraZeneca, Pfizer, Eli Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Takeda. F. Griesinger: Research funding to institution: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens; Consulting or advisory role: ARIAD, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, ARIAD, AbbVie, Siemens. E. Felip: Consulting/advisory role: AbbVie, AstraZeneca, Blue Print Medicines, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Guardant Health, Janssen, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda; Speakers bureau: AbbVie, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda. S. Popat: Research funding to institution: Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Roche, Lilly, Takeda; Honoraria: Boehringer Ingelheim, AstraZeneca, Roche, Takeda, Chugai Pharma; Consulting or advisory role: Boehringer Ingelheim, Roche, Novartis, Pfizer, AstraZeneca, BMS, MSD, Guardant Health, AbbVie; Travel, accommodations, expenses: Boehringer Ingelheim, BMS, Merck Sharp & Dohme. A. Morabito: Honoraria: AstraZeneca, Roche, Boehringer Ingelheim, Pfizer, MSD, BMS. S. Ghosh: Honoraria/speakers bureau: Pfizer. M. Tiseo: Speakers bureau, advisory role: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Otsuka, Pfizer, Pierre Fabre, Roche. J. Haney, D. Kerstein: Employment, stock and other ownership interests: Arîad. D.R. Camidge: Honoraria: AstraZeneca, Takeda, Arrys/Kyn, Genoptix, G1 Therapeutics (DSMB), Mersana Therapeutics, Roche/Genentech, Ignyta, Daichii Sankyo (ILD adjudication committee), Hansoh SRC, Bio-Thera DSMB, Lycera, Revolution Med, Orion, Clovis, Celgene, Novartis); Research funding (ARIAD/Takeda). All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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SCLC: New targets (ID 44)
- Event: ELCC 2019
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/13/2019, 08:00 - 09:30, Room A
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Immune targets and therapies for SCLC (ID 104)
08:00 - 09:30 | Presenting Author(s): Enriqueta Felip
- Abstract
- Presentation
Abstract not provided
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